The Spine-Tech™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Spine-Tech™ Cement Restrictor is NOT intended for any spinal indications.

Device Description

The Spine-Tech™ Cement Restrictor is a threaded, hollow cylinder that is manufactured from PEEK Optima LT1 with carbon fiber. This device is intended to be used in conjunction with PMMA cement.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Spine-Tech™ Cement Restrictor), focusing on its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics typically found in clinical trials or validation studies for AI/algorithm-based devices.

Therefore, most of the requested information cannot be extracted from this document.

Here's an assessment based on the provided text, indicating what information is not available:

1. Table of acceptance criteria and the reported device performance:

Not available. This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than setting or meeting specific performance acceptance criteria from a study.

2. Sample size used for the test set and the data provenance:

Not available. No test set or data provenance from a study is mentioned. The clearance is based on comparison to predicate devices, not specific performance data from a clinical or analytical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not available. No ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set:

Not available. No test set or adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not available. This device is a physical medical implant (cement restrictor), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable/Not available. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not available. No ground truth for a study is mentioned. The "ground truth" for 510(k) clearance is often the historical performance (safety and efficacy) of the predicate device(s).

8. The sample size for the training set:

Not available. No training set is mentioned as this is not an AI/algorithm device.

9. How the ground truth for the training set was established:

Not available. No ground truth for a training set is mentioned.

Summary based on the document:

The Spine-Tech™ Cement Restrictor received 510(k) clearance based on demonstrating substantial equivalence to two predicate devices:

RPX™ Titanium Cement Restrictor Device (K020344)
Medtronic Sofamor Danek Cement Restrictor PEEK Optima™ LT (K010528)

Equivalence was established based on:

Similarities of intended use: Both the subject device and predicates are intended for use as cement restrictors in orthopedic surgeries (e.g., femoral canal and tibial plateau in hip stem and total knee replacement).
Design similarities: All are cement restrictors. The subject device is a threaded, hollow cylinder manufactured from PEEK Optima LT1 with carbon fiber.
Physical characteristics similarities: Implied by the design and material, without specific physical characteristic data provided in this summary.

The FDA added a warning that the device is not intended for any spinal indications, and its safety and effectiveness when implanted in the spine have not been established. This indicates an assessment of where the device could potentially be used but its safety and efficacy are not proven for that specific use.

Summary

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OCT 2 9 2002

Centerpulse, Spine-Tech Division

『

	(21 CFR Part 807.92)
Submitter InformationA.
Submitter's Name:	Angela Byland
Address:	7375 Bush Lake RoadMinneapolis, MN 55439-2027
Telephone Number:	(952) 857-5631
Fax Number:	(952) 830-6388
Contact Person:	Angela Byland
Date Submission Prepared:	August 6, 2002
B.Device Information
Trade Name:Common or Usual Name:	Spine-Tech™ Cement RestrictorCanal Plug, Cement Restrictor
Classification Name:	(per 21 CFR Part 878.3300)
Device Classification:	Class II (per 21 CFR Part 878.3300)Panel -Orthopedic
Predicate Device:	RPX TM Titanium Cement Restrictor Device (K020344)
Comparative Device:	Medtronic Sofamor Danek PEEK Optima™ LT Cement Restrictor(K010528)
Subject Device Description:	The Spine-Tech™ Cement Restrictor is a threaded, hollowcylinder that is manufactured from PEEK Optima LT1 with carbonfiber. This device is intended to be used in conjunction withPMMA cement.
Intended Use:	The Spine-Tech™ Cement Restrictor is intended for use as acement restrictor in orthopedic surgeries such as those involvingthe femoral canal and tibial plateau in hip stem and total kneereplacement.
	The Spine-Tech™ Cement Restrictor is NOT intended for anyspinal indications.

510(k) Summary

C. Substantial Equivalence

The technological characteristics of the Spine-Tech™ Cement Restrictor Device are similar to the following predicate devices:

1. RPX™ Titanium Cement Restrictor Device (K020344), manufactured by Centerpulse, Spine-Tech Division and cleared by the FDA on May 2, 2002.
1. Medtronic Sofamor Danek Cement Restrictor PEEK Optima™ LT (K010528), manufactured by Medtronic Sofamor Danek and cleared by the FDA on October 10, 2001.

Establishment of equivalence is based on similarities of intended use, design, and physical characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2002

Ms. Angela Byland Senior Regulatory Affairs Specialist Centerpulseº - Spine-Tech Division 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027

Re: K022615

Trade Name: Spine-Tech" Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: September 27, 2002 Received: September 30, 2002

Dear Ms. Byland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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Page 2 - Ms. Angela Byland

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Daniel Schultz, M.D.

Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Spine-Tech™ Cement Restrictor

Indications for Use:

The Spine-Tech Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

PLEASE DO NOT WRITE BELOW THIS LINE---- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark N. Millman

(Division Sign-Off (Division Sign of General, Restorative Division ological Devices

510(k) Number K022615

Prescription Use
(Per 21 CFR 801.109)
✓

Over-the-Counter-Use (optional form at 1-2-96)

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.